CRE™ PRO

GUDID 08714729797562

Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter

BOSTON SCIENTIFIC CORPORATION

Gastrointestinal/biliary dilation balloon catheter, non-medicated
Primary Device ID08714729797562
NIH Device Record Key8c883305-8f9a-47bd-849e-e08e3834f1d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRE™ PRO
Version Model NumberM00558680
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729797562 [Primary]

FDA Product Code

FGECATHETER, BILIARY, DIAGNOSTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-12-23
Device Publish Date2015-10-21

On-Brand Devices [CRE™ PRO]

08714729797593Esophageal/Colonic/Biliary Wireguided Balloon Dilatation Catheter
08714729797586Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter
08714729797579Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter
08714729797562Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter
08714729797555Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter
08714729797548Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter
08714729797531Esophageal/Biliary Wireguided Balloon Dilatation Catheter
08714729797524Esophageal/Pyloric/Biliary Wireguided Balloon Dilatation Catheter
08714729797517Esophageal/Pyloric/Biliary Wireguided Balloon Dilatation Catheter
08714729797500Esophageal/Pyloric/Biliary Wireguided Balloon Dilatation Catheter
08714729797494Esophageal/Pyloric/Biliary Wireguided Balloon Dilatation Catheter
08714729797487Esophageal/Pyloric/Biliary Wireguided Balloon Dilatation Catheter

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